Employer Industry: Medical Devices

Why consider this job opportunity:
- Salary up to $133,200
- Eligible for a short-term incentive called the Medtronic Incentive Plan (MIP)
- Comprehensive benefits package including health, dental, and vision insurance
- Opportunities for professional development and career advancement
- Collaborative and innovative work environment focused on meaningful healthcare solutions
- Commitment to diversity and equal opportunity employment

What to Expect (Job Responsibilities):
- Develop and implement regulatory strategies for timely approvals from global regulatory bodies
- Collaborate with cross-functional teams to provide regulatory guidance and resolve potential issues
- Prepare and submit regulatory submissions, including Technical Files and Design Dossiers
- Maintain proficiency in global regulatory requirements and establish good relationships with agency personnel
- Manage regulatory submission activities for complex product development and maintenance of existing products

What is Required (Qualifications):
- Bachelor’s degree with a minimum of 4 years of regulatory experience in medical devices, biotech, or pharmaceutical industries, or an advanced degree with a minimum of 2 years of experience
- Strong written, verbal, presentation, and organizational skills
- Experience with regulatory requirements such as 21 CFR 820, ISO 13485, and EU MDR
- Ability to manage multiple projects and competing priorities effectively
- Knowledge of product development processes and design controls related to medical device regulations

How to Stand Out (Preferred Qualifications):
- Experience with Software as a Medical Device (SaMD) and Digital Health applications
- Regulatory Affairs Certification (RAC) or Master’s degree
- Familiarity with ISO 13485 and ISO 14971 standards
- Background in diabetes-related products
- Strong analytical and problem-solving skills

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